FUKUNDA SANGYO UNITS ELECTRONIC SPIRO

Spirometer, Diagnostic

FUTURE IMPEX CORP.

The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Fukunda Sangyo Units Electronic Spiro.

Pre-market Notification Details

Device IDK832430
510k NumberK832430
Device Name:FUKUNDA SANGYO UNITS ELECTRONIC SPIRO
ClassificationSpirometer, Diagnostic
Applicant FUTURE IMPEX CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-22
Decision Date1983-09-29

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